Efficacy and Safety of Polyoxidonium in Hospitalized Patients With Coronavirus Disease COVID-19
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- STATUS
- Recruiting
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- participants needed
- 394
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- sponsor
- NPO Petrovax
Summary
The purpose of this study is to demonstrate the superiority of Polyoxidonium, lyophilizate for solution for injections and topical application, 6 mg over placebo in hospitalized patients with coronavirus disease (COVID-19). This is a multicentre prospective, randomized, double-blind, placebo-controlled, parallel-group phase IIb\IIIa clinical trial.
Description
This is a multicenter prospective, randomized, double-blind, placebo-controlled, parallel-group phase 3 IIb\IIIa trial to evaluate the efficacy of Polyoxidonium, lyophilizate for solution for injections and topical application, 6 mg over placebo in hospitalized patients with coronavirus disease (COVID-19). A study will last for 293 days (maximum) for each participant and will include: screening (days -1...1); treatment period (17 days in total, days 1...17) with the administration of the investigational product Polyoxidonium/placebo (intravenous injections for 3 days, then intramuscular injections for 14 days), assessment of the clinical status, recording of AEs; follow-up period (days 18...293).
Haematology and blood chemistry tests will be performed at day -1 and days 1,3, 8 1, 171.
Assessment of the clinical status according to the 7-point ordinal scale and according to the National Early Warning Score (NEWS) scale will be done every day during hospitalization from day 1 up to and including day 17 and at the follow-up on day 293.
The safety and tolerability will be evaluated throughout the study (from signing the Informed Consent Form to the study completion visit).
Details
| Condition | Coronavirus Infection |
|---|---|
| Age | 18years - 85years |
| Treatment | Placebo, azoximer bromide |
| Clinical Study Identifier | NCT04381377 |
| Sponsor | NPO Petrovax |
| Last Modified on | 19 February 2024 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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